20
TESTING PROCEDURES
Collecting a sample
• The patient sample material and control material to be used are specific for each Alere Afinion™ test.
• The length of the capillary in the sampling device, and thereby the sample volume, might also vary for the different
Alere Afinion™ tests.
• The time from filling the capillary until analysing the Test Cartridge must be as short as possible.
• Do not use the Test Cartridge if dropped on the bench or floor after the sample has been collected.
Consult the Package Insert that comes with each Alere Afinion™ test kit for assay specific information.
Examples:
1
2
3
Remove the sampling device from the
Test Cartridge.
Use the handle to keep the Test
Cartridge steady against the table and
pull the sampling device straight up.
Fill the capillary; hold the sampling
device almost horizontally and bring the
tip of the capillary in surface contact
with the sample. Make sure that the
capillary fills completely. It is not
possible to overfill.
Do not wipe off the capillary.
Avoid air bubbles and excess sample
on the outside of the capillary.
Immediately and carefully replace the
sampling device into the Test Cartridge.
The time from filling the capillary until
analysing the Test Cartridge must be as
short as possible.
21
TESTING PROCEDURES
Analyzing a patient/control sample
1
Touch
to enter the patient sample mode.
Touch
to enter the control mode. A “C” in the upper left corner indicates that the Analyzer
is in the control mode.
The lid opens automatically.
If the lid is left open from the previous run and “Insert Cartridge” is displayed, this step is
omitted and you can start with step 2.
2
Insert the Test Cartridge with the barcode label facing left.
Be sure that the Test Cartridge is correctly placed in the cartridge chamber.
3
Close the lid manually.The Analyzer will start processing the Test Cartridge.
The processing time depends on the test in use.
4
Touch
and enter the patient ID.
Touch
to confirm.
Touch
and enter the control ID or Alere Afinion™ Control Data.
Touch
to confirm.
Entering the patient ID, control ID or Alere Afinion™ Control Data will not interrupt the processing.
5
Record the result, then touch
to accept.
If a printer is connected, touch
to print the result.
The lid opens automatically.
The result will be saved in the result records.
6
Remove the used Test Cartridge from the cartridge chamber and discard it in a suitable waste container.
Insert a new Test Cartridge or close the lid manually.
Keep the lid closed to protect the cartridge chamber when the Analyzer is not in use.
Consult the Package Insert that comes with each Alere Afinion™ test kit for assay specific information.
22
Using the operator ID function
Entering operator ID
If enabled, the operator’s identification (ID) is required before processing an Alere Afinion™ Test Cartridge. (see “Operator
Configuration” page 14).
Both letters and numbers can be entered (maximum 16 characters). The operator ID will be displayed with the result and stored
along with the other specific data for this run (see “Patient and control results records”, page 26).
If configured to “enabled with verification” the operator ID entered is required to be present in the operator ID list. (see “Operator
configuration” page 14).
Enter the operator ID by numbers and/or touch
to enter letters. If a barcode reader is connected to the
Analyzer, a barcoded operator ID can be entered.
Touch
to confirm and return to previous view.
The operator will be automatically logged out according to the configuration. (see “Operator configuration” page 14).
The operator may also manually logout by using the operator logout button
displayed in the Start-up menu.
Using the patient ID function
The patient ID function is enabled as a default setting. As long as this function is enabled, the patient ID must be entered for each
patient sample to be analyzed. The patient ID function can be disabled (see “Patient ID configuration”, page 13).
Entering patient ID
It is recommended to enter the patient ID during processing of the Test Cartridge in the Analyzer. Entering the patient ID will not
interrupt the processing. It is also possible to enter the patient ID before and after the processing.
1
Touch
to enter the patient ID option.
2
It is possible to enter up to four patient ID entries for each patient, P-ID 1 to 4. When enabled, P-ID 1 is
required to be entered. Scrolling between the patient IDs is done with the
and
.
Enter patient ID by numbers and/or touch
to enter letters. (maximum 16 characters).
If a barcode reader is connected to the Analyzer, a barcoded patient ID can be entered.
Touch
to confirm and return to previous view.
3
The entered P-ID 1 will appear on the screen.
The patient ID touch button will remain in the view and it is possible to make corrections.
The P-ID 1 will be stored in the memory and displayed along with the other specific data for this run (see “Patient ID configuration”,
page 13). Patient ID 2-4 will not be displayed in the result records but will be stored in the memory and appear on print outs and
data transferred to data management systems.
TESTING PROCEDURES